FDA Drug recall D-0242-2018
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in German…
- FDA Drug
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in German… by Boehringer Ingelheim Pharmaceuticals, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0242-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-14 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
Product
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
Reason
Failed Stability Specifications
Identifiers
| ndc | 0597-0075-41 |
|---|---|
| ndc | 0597-0075-75 |
| ndc | 0597-0075-47 |
| code_info | Lot # 606478; Exp. 03/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0242-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.